Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy
NCT ID: NCT02097446
Last Updated: 2014-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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* Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
* Primary Outcome Measure : Anti-adhesion Rate
* Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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GUARDIX-FL
Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day).
Guardix-FL
Interceed
Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).
Interceed
Interventions
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Guardix-FL
Interceed
Eligibility Criteria
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Inclusion Criteria
2. Women aged between 18 and 44
3. The patients who are able to participate in clinical trial during the period of study
4. The patients without abnormal figures at the screening laboratory examination
5. The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)
Exclusion Criteria
2. The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
3. The patients with severe drug allergy
4. The patients with infectious disease on abdominal or pelvic cavity
5. The patients who previously participated in another clinical trials within the past 30 days
6. The patients considered inappropriate for the study
7. The pregnant
8. The patients with severe renal disease
9. The patients with severe systemic diseases
18 Years
44 Years
FEMALE
No
Sponsors
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Genewel Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Joong Sub Choi, Ph.D
Role: STUDY_DIRECTOR
Hanyang University Seoul Hospital
Seong Hun Kim, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Hanyang University Seoul Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Genewel1301
Identifier Type: -
Identifier Source: org_study_id
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